First-line Advanced NSCLC PatientsPhase 2NCT06412471
A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
A Phase 2 study testing SSGJ-707, carboplatin and Pemetrexed in people with First-line Advanced NSCLC Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- First-line Advanced NSCLC Patients
- What is being tested?
- SSGJ-707, carboplatin and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2024to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Signed informed consent form.
Who cannot join
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of The Hunan Cancer Hospital
Changsha
Jia Li, 13975895664, 13975895664@163.com
About this study
This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.
Read the detailed description
This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.
- Conditions
- First-line Advanced NSCLC Patients
- Being tested
- SSGJ-707, carboplatin, Pemetrexed, paclitaxel, PD-1/L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-707Drug
bispecific antibody
carboplatinDrug
chemotherapy
PemetrexedDrug
chemotherapy
paclitaxelDrug
chemotherapy
PD-1/L1Drug
Immune checkpoint inhibitors
Paclitaxel-albuminDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | dose level 1 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed |
| Arm 2 | Experimental | dose level 2 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed |
| Arm 3 | Experimental | dose level 3 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed |
| Arm 4 | Experimental | PD-1/L1 combined with chemotherapy Receives: Drug: carboplatin; Drug: Pemetrexed; Drug: PD-1/L1 |
| Arm 5 | Experimental | dose level 1 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| Arm 6 | Experimental | dose level 2 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| Arm 7 | Experimental | dose level 3 of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| Arm 8 | Experimental | Selected dose of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| Arm 9 | Experimental | Selected dose of SSGJ-707 combined with chemotherapy Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: Paclitaxel-albumin |
| Arm 10 | Experimental | PD-1/L1 combined with chemotherapy Receives: Drug: carboplatin; Drug: paclitaxel; Drug: PD-1/L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 12 months
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 12 months
Secondary outcomes (1)
PFS
The efficacy end points
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start26 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-line Advanced NSCLC PatientsStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412471
- Sponsor's protocol ID
- SSGJ-707-NSCLC-II-02
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
- ClinicalTrials.gov ID
- NCT06412471
- Acronym / sponsor ID
- SSGJ-707-NSCLC-II-02
- Conditions
- First-line Advanced NSCLC Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.
Detailed description
This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: Pemetrexeddose level 1 of SSGJ-707 combined with chemotherapy |
| Arm 2 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: Pemetrexeddose level 2 of SSGJ-707 combined with chemotherapy |
| Arm 3 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: Pemetrexeddose level 3 of SSGJ-707 combined with chemotherapy |
| Arm 4 | Experimental | Drug: carboplatin, Drug: Pemetrexed, Drug: PD-1/L1PD-1/L1 combined with chemotherapy |
| Arm 5 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: paclitaxeldose level 1 of SSGJ-707 combined with chemotherapy |
| Arm 6 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: paclitaxeldose level 2 of SSGJ-707 combined with chemotherapy |
| Arm 7 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: paclitaxeldose level 3 of SSGJ-707 combined with chemotherapy |
| Arm 8 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: paclitaxelSelected dose of SSGJ-707 combined with chemotherapy |
| Arm 9 | Experimental | Drug: SSGJ-707, Drug: carboplatin, Drug: Paclitaxel-albuminSelected dose of SSGJ-707 combined with chemotherapy |
| Arm 10 | Experimental | Drug: carboplatin, Drug: paclitaxel, Drug: PD-1/L1PD-1/L1 combined with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Signed informed consent form.
Key exclusion criteria (5 listed)
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-707bispecific antibody | Drug | Arm 1, Arm 2, Arm 3, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
| carboplatinchemotherapy | Drug | Arm 1, Arm 10, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
| Pemetrexedchemotherapy | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| paclitaxelchemotherapy | Drug | Arm 10, Arm 5, Arm 6, Arm 7, Arm 8 |
| PD-1/L1Immune checkpoint inhibitors | Drug | Arm 10, Arm 4 |
| Paclitaxel-albuminchemotherapy | Drug | Arm 9 |
Primary outcome
ORR
Time frame: 12 months
Objective response rate
Safety and tolerability
Time frame: 12 months
Safety and tolerability assessed by incidence and severity of adverse events
1 secondary outcome
PFS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSGJ-707, carboplatin and Pemetrexed in people with First-line Advanced NSCLC Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Wu, MD, Ph.D (0731-89762302, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.